1. Investigates whether the health product is a medical device requiring registration with Thai FDA, determines its risk classification, grouping, and its route of submission.
2. Prepares and submits documents related to registration, renewal, commercial permission, follow-up until approval process.
3. Promptly informs manufacturer is there’s any feedback from authority to ensure successful product registration.
4. Maintains regulatory database for the company.
5. Prepares LPI and contacting with customs broker for medical devices or other product import clearance and delivery.
6. Monitors emerging trends regarding trending medical devices and industry regulations.
7. Develops and maintains standard operating procedures, local working practices, regulatory affairs policies, and procedures to ensure that regulatory compliance is maintained or enhanced.
8. Performs other related duties and responsibilities, on occasion, as assigned.